Nidek Receives FDA 510(k) Clearance for the MP-3 Microperimeter

Source: Nidek

Wednesday, October 12, 2016 | FDA Approval/Clearance , Product Releases , Nidek


The FDA has issued 510(k) clearance for Nidek's MP-3 Microperimeter, which measures local retinal sensitivity for functional assessment of the retina. The results can be displayed over a color fundus image, correlating retinal anatomy to retinal function.
 
For enhanced clinical assessment, the MP-3 now includes a wider range of stimulus intensity, from 0 to 34 dB, compared to the MP-1. The MP-3 measures perimetric threshold values, even for normal eyes. A maximum stimulus luminance of 10,000 asb allows evaluation of low-sensitivity. The Nidek auto tracking and auto alignment functions may provide more accurate measurements increasing patient and operator comfort and efficiency. These functions allow easy follow-up and reduce variations between examiners, resulting in well-aligned follow up exams.
 
Retinal morphology can be evaluated with the 12-megapixel fundus camera included in the MP-3 unit which acquires high resolution images of retinal pathology and allows easy image acquisition.
 
The MP-3 Microperimeter is now available in the United States.


Comments

You must be logged in to leave a comment.